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CompletedNCT06944132MMCUpdated Apr 25, 2025

CsA vs MMC for Preventing Pterygium Recurrence

An interventional study of Excision of the pterygium and Post-operative application of CsA in Pterygium and Pterygium of the Conjunctiva and Cornea, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.

Read the detailed description

A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.

02

Conditions studied

  • Pterygium
  • Pterygium of the Conjunctiva and Cornea

Keywords

  • pterygium
  • Mitimycin C
  • Cyclosporin A
03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 93 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older.
  • Diagnosed with primary pterygium extending at least 1 mm onto the cornea.
  • No prior history of pterygium surgery in the affected eye.

Exclusion criteria

Exclusion Criteria:

  • History of ocular surface diseases such as dry eye or Sjögren's syndrome.
  • Active ocular infection.
  • Known to CsA or MMC.
  • Systemic conditions requiring therapy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Group A (CsA Group)

    Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.

    Procedure: Excision of the pterygium · Drug: Post-operative application of CsA

  • Active comparator
    Group B (MMC Group)

    Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery

    Procedure: Excision of the pterygium · Drug: Intra-operative application of MMC

Interventions

  • ProcedureExcision of the pterygium

    The surgical procedure involved excision of the pterygium, including the fibrovascular head and associated conjunctival tissue, followed by bare sclera closure using an autologous conjunctival graft harvested from the superior bulbar conjunctiva. The graft was secured in place using either fibrin glue or 8-0 absorbable sutures. In Group B, 0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution.

  • DrugPost-operative application of CsA

    Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.

  • DrugIntra-operative application of MMC

    0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution.

06

What researchers measure

Primary outcomes

  1. recurrence rate of pterygium

    the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm

    Time frame: 6 months after surgery

Secondary outcomes

  1. Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.

    OSDI (from 0 to 100 points) where patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time" a final score is calculated which ranges from 0 to 100 with scores and based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease.

    Time frame: 6 months after surgery

  2. Change in clinical parameter Schirmer test (from 0 to 15 mm)

    The Schirmer test score is determined by measuring the length of the strips' moistened area against fluid movement

    Time frame: 6 months after surgery

  3. Change in clinical parameter (TBUT)

    Change in clinical parameter Tear breakup time (TBUT) from less than 5 to more than 10 seconds

    Time frame: 6 months after surgery

07

Study locations

1 site
  • Ebsar Eye Center
    Cairo, 4450113, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06944132
Lead sponsor
Benha University
Responsible party
Ehab Mohamed Elsayed Mohamed Saad (Lecturer, Benha University) — Principal investigator
First posted
Apr 25, 2025
Start date
Apr 1, 2024
Primary completion
Sep 30, 2024
Completion
Oct 15, 2024
Last update
Apr 25, 2025

Study contacts

Ehab Saad, Lecturer
principal investigator · Benha University, Ebsar Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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